Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-02-20 @ 6:43 PM
Study NCT ID:
NCT01909557
Status:
COMPLETED
Last Update Posted:
2013-07-26
First Post:
2013-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acetyl-L-Carnitine Supplementation During HCV Therapy With Peg IFN-α2b Plus Ribavirin: Effect on Work Performance.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000108', 'term': 'Acetylcarnitine'}], 'ancestors': [{'id': 'D002331', 'term': 'Carnitine'}, {'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-25', 'studyFirstSubmitDate': '2013-07-24', 'studyFirstSubmitQcDate': '2013-07-25', 'lastUpdatePostDateStruct': {'date': '2013-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Work performances', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acetyl-L-carnitine', 'Interferons', 'Ribavirin', 'Hepatitis C', 'Fatigue'], 'conditions': ['Quality of Life', 'Daily Activity', 'Fatigue']}, 'descriptionModule': {'briefSummary': 'To assess the effects of Acetyl-L-Carnitine, probiotics and antioxidant nutritional substances administration on work productivity, daily activity, and fatigue in subjects with chronic hepatitis C treated with Pegylated-Interferon-α2b and Ribavirin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible patients are workers who are 18 years of age or older, infected by HCV with a quantifiable serum HCV RNA level (as determined by polimerase chain reaction, COBAS AmpliPrep/COBAS TaqMan - ROCHE). HCV infected populations must have elevated serum alanine transaminase levels and findings on liver biopsy consistent with chronic infection. Cirrhotic patients have to have a Child-Pugh score less than 7 to be eligible.\n\nExclusion Criteria:\n\n* Ineligible patients are those who had other liver diseases, as well as those who are affected by cancer, severe jaundice, pulmonary and renal chronic diseases, prostatic diseases, autoimmune diseases and diabetes mellitus. Excessive use of alcohol (\\>20 g/die) or hepato-toxic drugs. Other causes of exclusion include decompensated cirrhosis, pregnancy, and contraindications for Peg-IFN-a or RBV therapy such as cardiopathy, hemoglobinopathies, hemocromatosis, major depression or other severe psychiatric pathological conditions.'}, 'identificationModule': {'nctId': 'NCT01909557', 'briefTitle': 'Acetyl-L-Carnitine Supplementation During HCV Therapy With Peg IFN-α2b Plus Ribavirin: Effect on Work Performance.', 'organization': {'class': 'OTHER', 'fullName': 'University of Catania'}, 'officialTitle': 'Effect of Supplementation of Antioxidant Substances and Probiotics in HCV Correlated Liver Disease Treated With Interferon and Ribavirin. Studies on Biochemical and Virological Response and on Quality of Life.', 'orgStudyIdInfo': {'id': 'Unict10/1997'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acetyl-L-carnitine', 'description': 'Acetyl-L-carnitine 2 gr tablets', 'interventionNames': ['Drug: Acetyl-L-carnitine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Acetyl-L-carnitine', 'type': 'DRUG', 'armGroupLabels': ['Acetyl-L-carnitine']}, {'name': 'placebo', 'type': 'DRUG', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95125', 'city': 'Catania', 'country': 'Italy', 'facility': 'University of Catania, Cannizzaro Hospital', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Catania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Mariano Malaguarnera', 'investigatorAffiliation': 'University of Catania'}}}}